Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.
Brief Title
506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma
Detailed Description
OBJECTIVES:
* Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority.
* Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients.
* Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients.
OUTLINE: Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for one year and then every 6 months until death.
PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.
* Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority.
* Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients.
* Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients.
OUTLINE: Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.
Patients are followed every 3 months for one year and then every 6 months until death.
PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Leukemia
Lymphoma
Eligibility Criteria
DISEASE CHARACTERISTICS:
* Histologically confirmed relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma
* Tumor cells should exhibit phenotypic characteristics of these diseases
* No CNS involvement requiring intrathecal or craniospinal radiotherapy
* Must not be eligible for Intergroup, Cooperative Group, or local research studies of higher priority
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* ECOG 0-3 OR
* Karnofsky 40-100%
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min
Other:
* No neuropathy grade 2 or higher
* No history of significant neurological toxicity (grade 2 or greater) associated with prior chemotherapy or radiotherapy
* No active seizure disorder
* No active infection
* No other active concurrent malignancy except curatively treated basal cell carcinoma or carcinoma in situ of the cervix
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior bone marrow transplantation allowed
* No concurrent allogeneic bone marrow transplantation
Chemotherapy:
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
* No prior 506U78
Endocrine therapy:
* No concurrent systemic steroid therapy
Radiotherapy:
* See Disease Characteristics
* Prior radiotherapy allowed
Surgery:
* Not specified
Other:
* No other concurrent investigational therapy
* No concurrent treatment for seizures
* Histologically confirmed relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma
* Tumor cells should exhibit phenotypic characteristics of these diseases
* No CNS involvement requiring intrathecal or craniospinal radiotherapy
* Must not be eligible for Intergroup, Cooperative Group, or local research studies of higher priority
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* ECOG 0-3 OR
* Karnofsky 40-100%
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min
Other:
* No neuropathy grade 2 or higher
* No history of significant neurological toxicity (grade 2 or greater) associated with prior chemotherapy or radiotherapy
* No active seizure disorder
* No active infection
* No other active concurrent malignancy except curatively treated basal cell carcinoma or carcinoma in situ of the cervix
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior bone marrow transplantation allowed
* No concurrent allogeneic bone marrow transplantation
Chemotherapy:
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
* No prior 506U78
Endocrine therapy:
* No concurrent systemic steroid therapy
Radiotherapy:
* See Disease Characteristics
* Prior radiotherapy allowed
Surgery:
* Not specified
Other:
* No other concurrent investigational therapy
* No concurrent treatment for seizures
Inclusion Criteria
DISEASE CHARACTERISTICS:
* Histologically confirmed relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma
* Tumor cells should exhibit phenotypic characteristics of these diseases
* No CNS involvement requiring intrathecal or craniospinal radiotherapy
* Must not be eligible for Intergroup, Cooperative Group, or local research studies of higher priority
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* ECOG 0-3 OR
* Karnofsky 40-100%
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min
Other:
* No neuropathy grade 2 or higher
* No history of significant neurological toxicity (grade 2 or greater) associated with prior chemotherapy or radiotherapy
* No active seizure disorder
* No active infection
* No other active concurrent malignancy except curatively treated basal cell carcinoma or carcinoma in situ of the cervix
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior bone marrow transplantation allowed
* No concurrent allogeneic bone marrow transplantation
Chemotherapy:
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
* No prior 506U78
Endocrine therapy:
* No concurrent systemic steroid therapy
Radiotherapy:
* See Disease Characteristics
* Prior radiotherapy allowed
Surgery:
* Not specified
Other:
* No other concurrent investigational therapy
* No concurrent treatment for seizures
* Histologically confirmed relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma
* Tumor cells should exhibit phenotypic characteristics of these diseases
* No CNS involvement requiring intrathecal or craniospinal radiotherapy
* Must not be eligible for Intergroup, Cooperative Group, or local research studies of higher priority
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Performance status:
* ECOG 0-3 OR
* Karnofsky 40-100%
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Bilirubin no greater than 2.0 mg/dL
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min
Other:
* No neuropathy grade 2 or higher
* No history of significant neurological toxicity (grade 2 or greater) associated with prior chemotherapy or radiotherapy
* No active seizure disorder
* No active infection
* No other active concurrent malignancy except curatively treated basal cell carcinoma or carcinoma in situ of the cervix
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior bone marrow transplantation allowed
* No concurrent allogeneic bone marrow transplantation
Chemotherapy:
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
* No prior 506U78
Endocrine therapy:
* No concurrent systemic steroid therapy
Radiotherapy:
* See Disease Characteristics
* Prior radiotherapy allowed
Surgery:
* Not specified
Other:
* No other concurrent investigational therapy
* No concurrent treatment for seizures
Gender
All
Gender Based
false
Keywords
recurrent adult acute lymphoblastic leukemia
T-cell adult acute lymphoblastic leukemia
recurrent adult lymphoblastic lymphoma
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
16 Years
NCT Id
NCT00003837
Org Class
Nih
Org Full Name
National Cancer Institute (NCI)
Org Study Id
CDR0000066994
Overall Status
Completed
Phases
Not Applicable
Official Title
Compound 506U78 (NSC 686673) in Patients With Relapsed or Refractory T-Cell ALL or T-Cell Lymphoblastic Lymphoma
Primary Outcomes
Outcome Measure
Provide an investigational agent to physicians for patients who are not candidates for entry onto ongoing research clinical trials of higher priority
Secondary Ids
Secondary Id
CTEP-TRC-9701
Secondary Id
CWRU-TRC-1499
Secondary Outcomes
Outcome Measure
Toxicity
Outcome Measure
Antitumor efficacy as defined by the rate of complete hematologic responses
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
16
Investigators
Investigator Type
Principal Investigator
Investigator Name
Joseph Sparano
Investigator Email
jsparano@montefiore.org
Investigator Phone
718-405-8404